Lead Technical Operations/ Technology Transfer (Formulations)

Role & responsibilities

Seamless transfer of Product, Process, Technology and knowledge from Development Lab. to Commercial Scale, while maintaining quality, compliance, cost-efficiency and supply continuity

1. New Product Technology Development :

- New Product Introduction (NPI) support

- Scale up of process from Development Lab. to Pilot and Exhibit Stage

- Equipment selection, Budgeting and Scale-up strategy development

- Coordinate RM, PM & Tooling for technology transfer

- Risk assessment and mitigation planning, Scale-up protocols and reports

- Cross-functional coordination with R&D, Manufacturing, Quality, PMO, Purchase, Regulatory and Engineering teams for timely execution of Registration batches

- Trouble shooting during scale-up and Exhibit batch execution

- Technology Development documentation and compliance

- Support Regulatory Deptt. in filing of dossiers

2. New Product Launch and Commercial Manufacturing support :

- Planning Process Evaluation and Process Validation batches along with Mfg. team

- Support to mfg. for timely new product launches, Life-cycle management and site transfers

- Process performance monitoring during initial commercial batches

- Process optimization and productivity improvement initiatives

- Management of post approval changes

- Trouble shooting & timely intervention to avoid disruption in market supply

- Support alternate vendor development for API & Excipients and participate in cost saving projects

- Support investigations of OOT, OOS, Deviations, Market or Customer complaints & CAPA

- Ensure compliance with cGMP, Quality Policy, EHS and SOPs. Identify and assess potential Occupational and Process safety hazard and take appropriate action

3. Analytical and Quality support

- Analytical Method Transfer co-ordination

- Ensure timely communication to ensure QC Laboratory readiness and qualification

- Stability Program support

- OOS/ OOT Investigation support

- Analytical method trouble shooting and optimization

4. Leadership & Development

- As a go-to resource for R&D/ Manufacturing for Process Knowledge and Scale-up strategy and keep upgrading the skill set continuously

- Budgeting for Technology Transfer activities

- Hiring, training, development and retention of team

- Developing best systems and practices for the function

Interested candidates can share your updated CV at [email removed]